Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Liver Resection

Liver Cancer Clinical Trial

Official title:

A Prospective Randomized Controlled Clinical Trial of Standard Compared to Goal-directed Perioperative Fluid Management (GDT) for Patients Undergoing Liver Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01596283
• Other study ID #: 12-056
• Status: Completed
• Phase: Phase 3
• First received: April 30, 2012
• Last updated: September 19, 2017
• Start date: April 2012
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to help us learn what is the best amount of fluid to administer to patients during liver surgery. Patients will receive either an amount for this surgery based on weight, blood pressure, heart rate and urine output or an amount guided by a computerized system (FloTrac) that helps doctors know how much fluid each patient needs. The FloTrac calculates the amount of fluid patients needs on a minute-to-minute basis, based on real time information like blood pressure, pulse and the ability of the heart and blood vessels to maintain normal vital signs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults (18 years old or greater) who are able to provide informed consent.

• Patients who undergo an open, elective liver resection. Including those initially approached laparoscopically but converted to an open resection and those undergoing additional procedures.

Exclusion Criteria:

• Active coronary disease.

• Patients with a history of coronary disease will be eligible if they have had a cardiac stress study showing no reversible ischemia and normal LV function within 3 months of operation.

• Active symptomatic cerebrovascular disease.

• Active congestive heart failure and ejection fraction <35%.

• Active severe restrictive or obstructive pulmonary disease and resting SpO2 <90%.

• Active renal dysfunction (Cr >1.8)

• Abnormal coagulation parameters (INR > 1.8 not on Coumadin, or platelet count < 100,000 per mcL)

• Presence of active infection including HIV

• Patients with active atrial fibrillation or flutter.

• Preoperative hypoalbuminemia (Albumin < 2g/dl).

• Female patients who are pregnant (female patients of child-bearing potential must have a negative serum pregnancy test = 14 days prior to surgery or 15 to 30 days prior to surgery with a negative urine pregnancy test the morning of surgery).

• Presence of ascites.

• BMI > 45 or <17

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

Procedure:
• Standard fluid management
The patient will receive standard fluid management

Device:
• Goal directed fluid therapy with the Edwards EV1000 system
This arm will have fluid therapy guided by the Edwards EV1000 system.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Complications	The incidence of overall 30-day postoperative complications will be recorded. These are defined in the MSKCC Adverse Events Program and organized by categories reflecting organ systems and further subdivided into specific complications within those and graded.	30 days post procedure
Secondary	Low Cardiac Output Time	Assess the impact of GDT compared to standard fluid therapy on the total time patients experience low cardiac output perioperatively	Up to the first 24 postoperative hours
Secondary	Total Volume of Fluid Used Perioperatively	Assess the impact of GDT compared to standard fluid therapy on the total volume of fluid given intraoperatively	Up to the first 72 hours postoperatively
Secondary	Total Volume of Fluid Used Postoperatively	Postoperative fluid volume	Postoperatively for the total admission time, up to 8 days
Secondary	Postoperative Length of Stay	Assess the impact of GDT compared to standard fluid therapy on net fluid balance for the total admission time	Postoperatively for the total admission time, up to 8 days

External Links

•   Memorial Sloan Kettering Cancer Center